The Japanese regulatory authorities granted full marketing approval for Celgene’s Revlimid® therapy as a treatment for patients with myelodysplastic syndromes (MDS) associated with 5q deletion abnormality. This latest clearance for the thalidomide analogue follows on from its approval in Japan in June as combination therapy with dexamethasone for the treatment relapsed or refractory multiple myeloma in patients who have previously received at least one standard therapy. Revlimid will be available in Japan through Celgene’s RevMate™ distribution program.
Revlimid was the first of Celgene’s small molecule, orally available immunomodulatory IMiDs® compounds to reach the market. The drug is approved in combination with dexamethasone for the second-line treatment of multiple myeloma in over 50 countries across Europe, the Americas, the Middle East, and Asia. In Australia and New Zealand, Revlimid is sanctioned as combination therapy for the treatment of patients whose disease has progressed after one therapy.
Approval in North America, along with several Latin American countries, Malaysia, Israel, Australia, and New Zealand has also been granted for Revlimid in the treatment of transfusion-dependent anemia caused by low- or intermediate-1-risk MDS associated with deletion 5q cytogenetic abnormalities. Celgene says similar applications are currently being evaluated in other countries. Clinical trials are also ongoing to evaluate Revlimid in the treatment of a range of hematological malignancies including non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Celgene reported net global Revlimid sales of $1.76 billion in 2009, up 28.8% on sales during 2008.